MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INNOVIAN CRITICAL CARE; PATIENT DATA MANAGEMENT SYSTEM

Catalog Number	MS20026
Medical Device Problem Codes	No Apparent Adverse Event (3189); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : ongoing.
Event or Problem Description
It was reported that a nurse was attempting to document an administered medication dose to a specific patient record but noticed after entering the information into the innovian system that the information was recorded for a different patient instead.It was verified that only the recording of information went wrong; the patients have received correct medications.
Additional Manufacturer Narrative
Device logs were provided however, they were corrupted and could not be opened.Therefore, investigation could not be performed, and root cause could not be determined.Note that that the innovian solution suite (including innovian critical care and innovian perioperative care) reached the end of service (eos) january 31, 2020, and end of life (eol) december 31, 2021.Additionally, the instructions for use for innovian critical care cautions users that it is not to be used for patient monitoring or diagnostic purposes.Always refer to the primary source of clinical data.A query of the complaint database show this as an isolated case.
Event or Problem Description
It was reported that a nurse was attempting to document an administered medication dose to a specific patient record but noticed after entering the information into the innovian system that the information was recorded for a different patient instead.It was verified that only the recording of information went wrong; the patients have received correct medications.

• Brand Name: INNOVIAN CRITICAL CARE
• Common Device Name: PATIENT DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784470587
• MDR Report Key: 18452151
• Report Number: 1220063-2024-00001
• Device Sequence Number: 7155103
• Product Code: MHX
• UDI-Device Identifier: 04049098049801
• UDI-Public: 04049098049801
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MS20026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown